Efficacy and Safety Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis B

Treatments: Drug: Tenofovir; Drug: Entecavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01063036

AI463-203

2009-015705-40 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to show that the combination of entecavir and tenofovir, is effective and well tolerated in chronic hepatitis B patients who have failed previous treatment.

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with chronic hepatitis B virus (HBV) infection; either hepatitis B-e antigen(HBeAg)-negative or HBeAg-positive
• Subjects must have a treatment failure to their current nucleoside/ nucleotide treatment regimen
• Prior entecavir and/or tenofovir monotherapy is allowed
• Subjects must have compensated liver function

Exclusion criteria

• Women who are pregnant or breastfeeding
• Evidence of decompensated cirrhosis
• Co-infection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)
• Moderate or severe renal impairment
• Recent history of pancreatitis
• Therapy with interferon, thymosin alpha or other immuno-stimulators within 24 weeks of being assigned to study drug into this study
• Prior entecavir/tenofovir combination therapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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144 participants in 1 patient group

Entecavir + Tenofovir

Experimental group

Treatment:

Drug: Entecavir

Drug: Tenofovir